2025 Spring International Convention of
The Pharmaceutical Society of Korea

2025 Spring
International Convention of PSK

04.21(MON) - 04.22(TUE)
D-37

Abstracts

P12-2

Regional pharmacovigilance centers: A cornerstone of drug safety information development

 

  • Sungho CHO1, Eunmi Choi1, Myungsik Yoo1, Hyunjoo Jung*1
  • 1Korea Institute of Drug Safety and Risk Management (KIDS), Seoul, Republic of Korea

The decentralized pharmacovigilance system has been in operation in Korea to encourage spontaneous reporting of drug adverse events (AEs). Regional Pharmacovigilance Centers (RPVCs) have played a key role, with 28 centers operating as of 2025. The purpose of this study is to introduce the role of RPVCs in Korea's pharmacovigilance system. Annual individual case safety reports (ICSRs) from the Korea Adverse Event Reporting System (KAERS) between 2014 and 2024 were analyzed. The quantity and quality of ICSRs from RPVCs were compared with other sources. Also data on educational, promotional, and counseling activities were examined. From 2006 to 2013, as the number of RPVCs increased, the total ICSRs collected in Korea also rose proportionally. From 2014, RPVCs contributed about 70% of total ICSRs (Number of ICSRs: RPVCs vs. MAHs – 170,433 vs. 75,241). Their reports showed higher completeness than those from marketing authorization holders (MAH) (Completeness Score: RPVCs vs. MAHs – 95.4 vs. 70.4). RPVCs have actively promoted AE reporting through education and consultations, conducting 2,700 educational activities and 37,600 AE consultations in 2024 alone. As core parts of Korea’s pharmacovigilance system, RPVCs contribute significantly to drug safety and should further expand their role to strengthen pharmacovigilance efforts. 


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TODAY 2025. 03. 15

2025 Spring Convention

D-37

Conference infomation

Conference Schedule
Apr. 21(Mon) ~ 22(Tue), 2025
Conference Venue
Daegu Exhibition & Convention Center (EXCO) 10 Exco-ro, Buk-gu, Daegu, Republic of Korea
Location
Early Registration Period
Feb. 24(Mon) ~ Mar. 21(Fri), 2025
Abstract Submission Period
Feb. 24(Mon) ~ Mar. 21(Fri), 2025
Certificate of Attendance